Urgent Notification
Package Insert Update for MLB2 Modified LISS Solution
DATE NOTIFICATION INITIATED:
February 12, 2009
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Package Insert Number 187734 Version 06
Product Number: 805 200 100
| Lot Number | Expiration Date |
|---|---|
| 7738020 | 10/04/2009 |
| 7830101 | 07/31/2010 |
MANUFACTURER:
Biotest AG - Dreiech
Dreieich, Germany
REASON:
Biotest has notified their customers regarding an ambiguous statement in their package insert which incorrectly stated the centrifugation parameter. The centrifugation parameter should be 20 seconds at (800-1000 x g) for tube testing. Customers are requested to replace the product insert version 06 with the new package insert version 07.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.